Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder; Guidance for Industry and Food and Drug Administration Staff; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder." Design of clinical studies for devices intended to treat opioid use disorder (OUD) is challenging. To help spur innovative options to combat the opioid overdose crisis and treat OUD, this guidance provides recommendations on the design of pivotal clinical studies for devices intended to treat OUD (OUD device studies). Through these recommendations, FDA intends to aid sponsors in developing OUD device studies that provide scientific evidence used to determine whether there is a reasonable assurance of safety and effectiveness for treating OUD.